Kornimate/medical-research-clean huggingface dataset:
acupressure for fatigue and low back pain

Conditions: Fatigue; Chronic Low Back Pain

Summary: the purpose of this study is to compare two kinds of self-administered acupressure (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue and pain in low back pain patients. hypothesis: self-administered relaxation acupressure will result in improvements in fatigue and sleep quality, pain, and physical function compared to stimulating acupressure and usual care.

acupressure is a traditional chinese medicine (tcm) technique based on a philosophy similar to that of acupuncture. it involves the application of physical pressure on different acupuncture points (acupoints). one advantage of acupressure is the ability to self-administer the treatment. acupressure is also a viable alternative to acupuncture in situations where patients: (1) cannot come to the clinic to receive an acupuncture treatment; (2) when a more frequent intervention is needed; or (3) where needle phobia or safety concerns are an issue. the objective of this study is to evaluate the validity and feasibility of teaching acupressure interventions using an acupressure educator for the management of symptoms related to low back pain. specific aims: 1. to examine the effect of 6-weeks of relaxation acupressure (ra) compared to a regime of stimulating acupressure (sa) or wait-list control (wl) on fatigue and sleep quality as assessed by brief fatigue inventory and wrist-worn accelerometry (sleep efficiency). 2. to explore the effect of 6-weeks of ra compared to a regime of sa or wl on for chronic low back pain in terms of reduced pain and improved function.

Eligibility criteria:
inclusion criteria: * aged18-65 years * non-specific low back pain (either by self-report or via icd-9 codes 724.2, 724.5, 846.0-846.9) * low back pain that has persisted for at least 3 months * minimum of 3/10 on the pain bothersome scale * minimum of 3/10 fatigue severity * ambulatory with or without assistive device * ability to operate the accelerometer (actiwatch-s) * stable medication regiment for the previous 2 months * report of a physician's visit during the previous 24 months * english-speaking exclusion criteria: * medically unstable (acute conditions or acute presentations of chronic conditions) * current pregnancy * radiculopathy or report of low back pain radiating to below the knee * reported history of spinal fracture, herniated lumbar disc, ankylosing spondylitis, and spinal stenosis. * report of back surgery within the preceding 12 months * participation in active litigation or compensation claims * conditions that might confound treatment effects or interpretation of results (for example, rheumatoid arthritis, lupus) * acupuncture or acupressure within the preceding 12 months * report of sleep apnea * 2nd or 3rd shift workers or other non-traditional sleep schedules * use of anti-coagulant/platelet therapy within the preceding month

Keywords: pain acupressure symptoms fatigue self-administered
oral low-dose naltrexone for lichen planopilaris and frontal fibrosing alopecia

Conditions: Lichen Planopilaris; Frontal Fibrosing Alopecia

Summary: oral naltrexone was initially fda approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. at lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. a recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. there were no reported adverse events. based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. the patients would be continued on their other medications for these conditions. the study would be open-label, so all participants would receive the low-dose naltrexone. patients would be seen at 0,3,6 and 12 months to monitor their progress.


Eligibility criteria:
inclusion criteria: * adults age 18 or greater * clinically or histologically confirmed diagnosis of lichen planopilaris or frontal fibrosing alopecia exclusion criteria: * known allergy or hypersensitivity to naltrexone * patients with concurrent use of opioids * active depression, schizophrenia, and bipolar disorder
overnight pant study for children with nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: this study will evaluate the in-use tolerance of an absorbent disposable underwear pant developed for children with nocturnal enuresis by assessing adverse events. in addition product performance will be assessed by the parent at home via a daily diary.


Eligibility criteria:
inclusion criteria: participants are eligible for enrollment if the parent/legal guardian responds positively ("yes") to the following questions: 1. have you read, understood and signed the informed consent document? 2. is your child generally healthy? 3. is your child 4-7 years of age? 4. does your child weigh approximately 37-63 pounds and fit into the test pant? 5. thinking of the past 3 months, does your child wet the bed at night at least once per week? 6. is your child currently using overnight pants or diapers? 7. is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study? 8. are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial? 9. are you willing to refrain from enrolling your child in other clinical or consumer studies for the duration of this clinical trial? 10. are you and your child willing to refrain from using lotions, creams, ointments, oils, moisturizing bubble baths, powders, sunscreen and/or skin preparations in the child's pant area and on thighs for the duration of this clinical trial, unless required for medical reasons? 11. are you and your child willing and able to comply with all study instructions? 12. are you able to fill in the required questionnaires in english? exclusion criteria: participants are ineligible for enrollment if the parent/legal guardian responds positively ("yes") to any of the following questions: 1. does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area? 2. does your child currently have (or have a history of) any significant illness or chronic medical condition? 3. is your child currently using any medications? 4. does your child currently wear absorbent products during the day? 5. does your child suffer from any other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a history of bladder dysfunction?
an idiographic examination of treatment mechanisms in emotion regulation therapy

Conditions: Rumination; Worry; Self-Criticism; Anxiety; Depression; Distress, Emotional

Summary: this study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of emotion regulation therapy (ert) delivered via telehealth for individuals in new york state who are experiencing elevated worry, rumination, or self-criticism.

the main questions this study aims to answer are to: 1. examine temporal patterns of ert-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (nsrp; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules. 2. investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction. 3. demonstrate the preliminary efficacy of a 12-session version of ert in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ert-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning. participants will: 1. fill out an online pre-screening questionnaire and complete a structured clinical interview via zoom healthcare 2. be enrolled as a patient at the dean hope center for educational and psychological services (dhceps), located at teachers college 3. attend 12 once-weekly telehealth ert sessions 4. complete 18 weekly questionnaires online via qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 * fluent in english (and therefore able to provide consent) * currently living in new york state * access to at least one device with internet and video-conferencing capabilities * high self-reported worry, rumination, and/or self-criticism * meet diagnostic and statistical manual of mental disorders - fifth edition (dsm-5) criteria for at least one, current psychological disorder exclusion criteria: * active suicidal ideation or intent * substance dependence disorder, schizophrenia, bipolar-i disorder, or a primary dsm-5 diagnosis of borderline or narcissistic personality disorder * currently in therapy or receiving any type of psychosocial treatment * individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months * current students at teachers college, columbia university

Keywords: worry rumination self-criticism emotion regulation therapy emotion regulation treatment mechanisms
the effect of stress, anxiety, and depression experienced by pregnant women on sleep bruxism and oral health

Conditions: Sleep Bruxism, Adult; Stress; Depression; Anxiety; Pregnancy Related; Oral Disease

Summary: background the oral health of pregnant women affects not only the systemic health of the mother but also the birth outcome of the fetus. therefore, oral health management of pregnant women is important for both maternal and fetal health. objectives the study aimed to examine the effects of stress, anxiety, and depression experienced by pregnant women on sleep bruxism and oral health. methodology this cross-sectional study was conducted between september and november 2023 on 321 pregnant women who volunteered to participate in the study by posting on social media forum pages via the web. data were collected using the personal information form, depression-anxiety-stress scale (dass-21), and oral health impact scale (ohip-14-tr). descriptive statistical methods, the kruskal-wallis test, mann-whitney-u test, and spearman correlation test were used to analyze the data.


Eligibility criteria:
inclusion criteria: * pregnant women over the age of 18 who were pregnant, diagnosed with sleep bruxism, and who could read and write were included in the study. exclusion criteria: * women who refused to participate in the study, who could not be contacted, who had serious dental health problems in the last six months, who had dentures, who had serious stress disorder in the last six months, who filled out the data collection form incompletely, who had hearing-vision problems or intellectual disability, and who had diagnosed psychological illness were not included in this study.
cluster-randomized trial measuring integration of professional midwives and obstetric nurses in rural clinics in mexico

Conditions: Pregnancy

Summary: rates and causes of maternal mortality in mexico have dropped only slightly; thus, reaching the internationally established millennium development milestones (mdm) is still a distant goal. a fundamental part of reducing maternal and infant mortality is ensuring skilled attendance during pregnancy and delivery. this project uses an innovative strategy of integrating professional midwives and licensed obstetric nurses into rural medical centers in the states of guerrero and oaxaca, mexico, to provide prenatal care, delivery services, and puerperium care. the goal of the research is to increase use of best practices in intake, labor, delivery, and puerperium care; decrease the use of unnecessary or harmful care; and improve maternal and neonatal outcomes. we posited that medical centers receiving the intervention would provide better care and have better maternal and neonatal outcomes than those that did not receive the intervention.


Eligibility criteria:
inclusion criteria: * clinics containing one medical team only (1 doctor and accompanying staff) * clinics less than 2 hours away from a referral hospital * clinics where at least 25 deliveries took place in the previous year exclusion criteria: * clinics inaccessible by car * clinics undergoing remodeling

Keywords: prenatal care maternal mortality perinatal mortality perinatal puerperium puerperium care midwives midwife obstetric nurse integration alternative personnel skilled attendant birth attendant delivery delivery services best practices rural
a study of the effect of time on topical anesthetic efficacy.

Conditions: Pain

Summary: this is a study of the effect of time on the effectiveness of topical anesthetics in the mouth. the null hypothesis is: regardless of the time of application over a 10-minute period, there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic administration.

the study design will be a double blind randomized controlled split-mouth clinical trial. it is proposed to compare the effectiveness of the standard topical anesthetic 5% lidocaine with a placebo over the time period of 2, 5 and 10 minutes after application. the topical will be placed on the palatal soft tissue where the perception of pain is the highest in the oral cavity. both the pain of needle insertion and the pain of local anesthetic injection will be compared.

Eligibility criteria:
inclusion criteria: 1. in good health (asa 1 or asa 2) 2. weight between 40-100kg, inclusive. 3. between ages 18-70, inclusive. 4. informed consent exclusion criteria: 1. asa 3 or higher. 2. history of allergy to sulfites, lidocaine or mepivacaine. 3. taking any analgesic 48hrs before testing, such as an nsaid, opioid, or acetaminophen. 4. pregnancy. 5. recent oral trauma. 6. lack of informed consent.

Keywords: topical anesthetic pain
implementation of a non-invasive version of the imaging β-adrenergic-dependent sweat secretion test

Conditions: Mucoviscidosis Involving the Lung

Summary: the goal of this study is to implement a non-invasive version of the sweat secretion test based in visualization of sweat glands following β-adrenergic stimulation of sweat. specifically, the trial will evaluate the relative response of sweat glands to β-adrenergic and cholinergic stimulation among participants with cf, heterozygous and matched control subjects


Eligibility criteria:
inclusion criteria: * for patients with cystic fibrosis: clinically stable, all genotypes included. * for healthy volunteer and heterozygous subjects: 18 years and older. exclusion criteria: * corticosteroids, anti-leukotriene therapy, unstable clinical status, \<40% fev1. * current pregnancy or breastfeeding.
study of sacituzumab govitecan versus treatment of physician's choice in participants with endometrial cancer after platinum-based chemotherapy and immunotherapy (ascent-gyn-01/gog-3104/engot-en26)

Conditions: Endometrial Cancer

Summary: the goal of this clinical study is to find out how the study drug, sacituzumab govitecan (sg) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (tpc). the primary objectives of this study are to evaluate the effect of sg compared to tpc on progression-free survival (pfs) as assessed by blinded independent central review (bicr) and overall survival (os).


Eligibility criteria:
key inclusion criteria: * documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma). * up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-pd-1/pd-l1 therapy, either in combination or separately. * eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator. * radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (ct) or magnetic resonance imaging (mri) per recist v1.1. * eastern cooperative oncology group performance status score of 0 or 1. * adequate organ function key exclusion criteria: * uterine leiomyosarcoma and endometrial stromal sarcomas are excluded. * participants who are candidates for curative-intent therapy at the time of study enrollment. * participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator. * received any prior treatment with a trop-2-directed antibody-drug conjugate (adc). * have an active second malignancy. * have an active serious infection requiring systemic antimicrobial therapy. * have active chronic inflammatory bowel disease (ulcerative colitis, crohn's disease) or gastrointestinal perforation within 6 months prior to randomization. * have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth. note: other protocol defined inclusion/exclusion criteria may apply.
neurofeedback and computerized cognitive training in different settings for children and adolescents with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention deficit/hyperactivity disorder (adhd) is among the most common childhood-onset psychiatric disorders, with a negative and long-lasting impact on academic achievement, social integration and quality of life. in recent years, the efficacy of non-pharmacological treatments for adhd, such as neurofeedback training (nf) and computerized cognitive training (cct), has been at the centre of research. although an increasing number of well-designed studies have shown that both methods may improve adhd core symptoms according to parents' ratings, the underlying mechanisms are still a matter of debate. teachers often report smaller improvements, if any. this has been explained by their lesser involvement in the training. it remains questionable, however, whether other factors may also account for this effect and whether methods other than placebo control may be applied in order to demonstrate the specificity and efficacy of nf and cct. the main purpose of this project is to demonstrate and compare the efficacy of two different computer-based treatment methods for children and adolescents with adhd, namely nf and cct, and to examine the impact of different treatment settings, with half of the participants being trained in a clinical setting and the other half at school. the investigators want to show that is feasible to implement nf and cct in a school setting and that both methods, conducted either at school or in a clinical setting, may lead to significant improvements of adhd symptoms as well as to specific and differential effects. besides the differential impact of the settings on informant ratings, the investigators will evaluate the effects of the training methods on neuropsychological and electrophysiological outcome. classroom behavior of the children before and after the training will be evaluated by trained observers not informed on treatment assignments and settings.


Eligibility criteria:
inclusion criteria: * adhd (dsm iv) exclusion criteria: * estimated iq \< 80 * known neurological impairment / brain injury * severe comorbid conditions (e.g. cd, odd, autism)

Keywords: adhd, neurofeedback, computerized cognitive training, school
menstrual differences in airway inflammation in asthma

Conditions: Asthma

Summary: asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness and reversible airway obstruction. over the last decade, the prevalence of asthma is on the rise and it disproportionately affects more women than men. as much as 40% of women with asthma are known to have worsening of asthma symptoms and lung function prior to menstruation. this syndrome is being increasingly recognized as premenstrual asthma (pma). the pathologic differences in female asthmatics with and without this syndrome are not known. the evidence regarding the role of sex hormones has been contradicting. we propose an observational cohort study to examine the changes in airway inflammation in women with asthma in relation to their menstrual cycle and their association with sex hormone levels. in addition we will include women on oral contraceptives to determine their effect on airway inflammation and asthma symptoms. we hypothesis that: * women with premenstrual asthma will show increased indices of airway inflammation in various phases the monthly menstrual cycle. * in women with premenstrual asthma, a change in serum estradiol/progesterone ratio during the late luteal phase is associated with worsening of airway inflammation, air flow limitation and asthma symptoms. * the use of oral contraceptives is associated with suppression of the cyclical changes in airway inflammation due to lack of fluctuations in estradiol and progesterone levels. recruited subjects will be asked to record asthma symptom scores, morning peak expiratory flow rate (m-pefr) and rescue asthma medication (β2-agonist) used daily during the one month screening period to identify women with and without pre-menstrual asthma. asthmatic women with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and luteal phase (days 21-24) and women on oral contraceptive pills (ocp) will be evaluated on days 9-12 of their ocp cycle and during the days 25-28, off of ocp consecutively for a 2-month period.


Eligibility criteria:
inclusion criteria: * with diagnosis of asthma (icd-9 code 493) * requiring low to moderate dose inhaled corticosteroids for control. * with pre-bronchodilator fev1 ≥50% and ≤90% of predicted normal * with a positive bronchodilator response * non smoker or ex-smoker (quit \>1 year ago) * regular menstrual cycle (24-35 days cycle) * with and without ocp use * constant dose of asthma maintenance medication for at least 30 days prior to enrolment exclusion criteria: * recent use of systemic steroids (\<30 days) * severe asthma (fev1 \<50% or frequent exacerbations or systemic steroid dependence) * negative bronchodilator response * current smoker * irregular menses or postmenopausal * positive pregnancy test * use of hormonal contraceptives other than monophasic ocps * exacerbation or respiratory infection or antibiotic use within the last 30 days